(29 days)
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.
Ambulatory (Holter) ECG intended use:
The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes.
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
- Clinical and epidemiological research studies.
- Evaluation of patients with pacemakers
- Reporting of time and frequency domain heart rate variability
- Reporting of QT Interval
The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).
The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.
| Attribute | DXP1000 | Model #1005 |
|---|---|---|
| Storage capacity | Up to 48 hours | 24 hours |
| Memory type | Flash (non-volatile) | Flash (non-volatile) |
| Memory portability | Non-removable | Non-removable |
| On-board ECG analysis | No | Yes |
| Liquid Crystal Display (LCD) | Yes | No |
| Data transfer method | USB port | Bi-directional parallel I/O |
| Pacemaker detection & reporting | Yes | Yes |
| Belt clip | Yes | No |
| Battery | One AA | Four AA |
| Size | 11 x 7 x 2cm | 15 x 6 x 2 cm |
| Weight | 135g | 140 g |
The provided text describes a 510(k) submission for the DXP1000 Holter Recorder, focusing on modifications and demonstrating substantial equivalence to a predicate device (Biosensor Model #1005).
Here's an analysis of the acceptance criteria and the study information available in the provided text:
Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate: Model #1005) | Reported Device Performance (DXP1000) |
|---|---|---|
| Pacemaker detection | Yes | Yes |
| Pacemaker reporting | Yes | Yes |
| Storage capacity | 24 hours | Up to 48 hours |
| Memory type | Flash (non-volatile) | Flash (non-volatile) |
| Memory portability | Non-removable | Non-removable |
| On-board ECG analysis | Yes | No |
| Liquid Crystal Display (LCD) | No | Yes |
| Data transfer method | Bi-directional parallel I/O | USB port |
| Belt clip | No | Yes |
| Battery | Four AA | One AA |
| Size | 15 x 6 x 2 cm | 11 x 7 x 2 cm |
| Weight | 140 g | 135 g |
Note: The primary focus of the modification and validation was the "pacemaker detection logic." The other attributes in the table represent direct comparisons of specifications between the modified device and the predicate.
Study Information
The provided text offers very limited details about the actual study conducted to validate the modified pacemaker detection logic. Here's what can be inferred:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states that "ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956)." This indicates the DXP1000 is a recorder only, and any AI/analysis component would be in separate software. Therefore, there's no mention of human readers or AI assistance effect sizes for this specific device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone validation of the "pacemaker detection logic" was performed. The text states, "the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." This validation pertains to the device's inherent capability to detect pacemakers.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given it's pacemaker detection, the ground truth would likely involve expert review of ECG traces or potentially verified pacemaker presence/absence records coupled with ECG data where pacemaker spikes are either known to be present or absent.
-
The sample size for the training set:
- Not specified. The document focuses on validation of a modified logic, implying existing development, but does not detail a training set for a new AI model.
-
How the ground truth for the training set was established:
- Not specified. Assuming any "training" (if applicable, perhaps during the initial development of the pacemaker detection logic in the predicate device or an earlier iteration) involved expert review of annotated ECG waveforms.
In summary: The provided text is a 510(k) summary for a modified Holter recorder. It focuses on physical changes to the device and a slight modification to the pacemaker detection logic. While it states this logic was "validated," it provides minimal details regarding the methodology, sample sizes, ground truth establishment, or expert involvement in that validation study. The document explicitly differentiates this recorder from the ECG analysis software, which would be subject to separate review and where more detailed performance studies for algorithms might be expected.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).